CliniMACS PBS/EDTA Buffer 1L 700-25

GUDID 04049934004672

CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of the CliniMACS CD34 Reagent System. The CliniMACS® CD34 R

Miltenyi Biotec GmbH

Magnetic cell separation system buffered saline solution
Primary Device ID04049934004672
NIH Device Record Keyc0e16d0f-fdfc-442f-932e-a2e5c988860b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCliniMACS PBS/EDTA Buffer 1L
Version Model Number70026
Catalog Number700-25
Company DUNS327036034
Company NameMiltenyi Biotec GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-810-3135
EmailRegulatory_Affairs_USA@milteny

Device Identifiers

Device Issuing AgencyDevice ID
GS104049934001666 [Unit of Use]
GS104049934004672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

On-Brand Devices [CliniMACS PBS/EDTA Buffer 1L]

04049934004672CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of t
04049934004674CliniMACS® PBS/EDTA Buffer is a single-use, sterile, isotonic buffer solution used as part of t

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